TriangleNCT02314247 · OUTCOME
Overall Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 80% Confidence Interval
- Time frame
- Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression.
What was measured
Overall Response (OR) = Complete Response (CR) + Partial Response (PR). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. Progression was defined as the first occurrence of progressive disease (PD) per the revised response criteria. Clinical disease progression in the absence of formal criteria for PD must be documented by a physician.
Analysis population: Due to the limited enrollment in this study, only the Intent to Treat (ITT) Population, consisting of all patients who received at least 1 dose of study treatment (which is identical to the Safety Population), was evaluated for efficacy.
Groups in this outcome
Selinexor (PTCL)
Assigned to 60 mg dose, 6 doses/cycle
Selinexor (CTCL)
Assigned to 60 mg dose, 6 doses/cycle (6 patients); Assigned to 60 mg dose, 8 doses/cycle (1 patient)
| Group | Source count |
|---|---|
| Selinexor (PTCL) | 9 |
| Selinexor (CTCL) | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Selinexor (PTCL) | 11.1 | Not reported | 1.2 | 36.8 | Not reported |
| Selinexor (CTCL) | 14.3 | Not reported | 1.5 | 45.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.2
- upper Limit
- 36.8
- value
- 11.1
- group Id
- OG001
- lower Limit
- 1.5
- upper Limit
- 45.3
- value
- 14.3
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- Overall Response (OR) = Complete Response (CR) + Partial Response (PR). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. Progression was defined as the first occurrence of progressive disease (PD) per the revised response criteria. Clinical disease progression in the absence of formal criteria for PD must be documented by a physician.
- dispersion Type
- 80% Confidence Interval
- groups
- description
- Assigned to 60 mg dose, 6 doses/cycle
- id
- OG000
- title
- Selinexor (PTCL)
- description
- Assigned to 60 mg dose, 6 doses/cycle (6 patients); Assigned to 60 mg dose, 8 doses/cycle (1 patient)
- id
- OG001
- title
- Selinexor (CTCL)
- param Type
- NUMBER
- population Description
- Due to the limited enrollment in this study, only the Intent to Treat (ITT) Population, consisting of all patients who received at least 1 dose of study treatment (which is identical to the Safety Population), was evaluated for efficacy.
- reporting Status
- POSTED
- time Frame
- Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression.
- title
- Overall Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice